510(k) K093882 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
SORIN C5 SYSTEM MODEL 58-00-00
| Applicant | Sorin Group Deutschland GmbH, North Attleboro MA, US |
| Decision | Substantially Equivalent, Jan 15, 2010 |
| Received | Dec 18, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093882
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2014 | Sorin Group Deutschland GmbH S5/C5 Heart-lung machine
Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. Terminated |
DTQ | None listed |
| Nov 8, 2012 | Sorin Group USA, Inc. S5 Single Roller Pump 150, Item Number: 10-80-00
The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Terminated |
DTQ | None listed |
| Nov 8, 2012 | Sorin Group USA, Inc. S5 Double Roller Pump 85, Item Number: 10-85-00
The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Terminated |
DTQ | None listed |
| Nov 8, 2012 | Sorin Group USA, Inc. S5 Mast Roller Pump 85, Item Number: 10-88-60
The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Terminated |
DTQ | None listed |
| Nov 8, 2012 | Sorin Group USA, Inc. S5 Mast Roller Pump 150, Item Number: 10-88-00
The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Terminated |
DTQ | None listed |
| Nov 8, 2012 | Sorin Group USA, Inc. Sorin C5 Perfusion System, Item number 58-00-00
The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Terminated |
DTQ | None listed |
| Mar 29, 2012 | Sorin Group Deutschland GmbH Sorin C5 (perfusion system)
The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. Terminated |
DTQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.